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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-475-10
Device Problems Break (1069); Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/20/2019
Event Type  malfunction  
Manufacturer Narrative
The device has been received and device evaluation anticipated, but not yet begun. Upon completion of the device evaluation a supplemental report will be filed. Related mdrs for this event: 2029214-2019-00892. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that a pipeline flex device did not open at the distal segment during a procedure. Second pipeline flex device tip broke of the pushwire. The patient underwent embolization treatment for an unruptured saccular aneurysm located in left cavernous segment. Measuring 8mmx5mm, landing zone distal 4. 5mm proximal 3. 5mm. The vessel was moderately tortuous. It was reported that the guidecatheter was placed through the max sheath and placed into the petrous segment for support. The medtronic microcatheter was placed into the middle cerebral artery (mca) and the first device was advanced through the catheter. The pipeline flex device advanced normally but the device failed to open distally. The device was re-sheathed several times in an effort to get the device to open. After several attempts the device was removed and a new device was inserted. The second pipeline device (same lot number) was advanced through the same catheter to the tip of the catheter. The pipeline device was deployed per ifu and as the device was being dragged back into position, the distal end of the pipeline fell into the aneurysm. The pipeline was constrained to allow the device to be advanced again and resistance was noticed while the pipeline was being re-sheathed. The resistance changed suddenly, and it was noticed that the tip wire was disconnected from the delivery system. The physician removed the delivery system, catheter and guide catheter as a unit and all parts of the system were removed successfully without incident. It should be noted that the pipeline device was found in the guide catheter and the tip wire had to be removed from the femoral sheath with hemostats. The physician then completed the case using a non-medtronic stent and coils. There were not any patient symptoms or complications associated with this event. No patient injury was reported. Patient was treated with stent/coil and was angiographically fine post procedure.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key8955979
MDR Text Key168451691
Report Number2029214-2019-00893
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/18/2022
Device Model NumberPED-475-10
Device Lot NumberA817769
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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